Efficacy of Rifaximin in Patients With Small Intestinal Bacterial Overgrowth Presenting With Abdominal Bloating: An Exploratory Study.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Abdominal bloating is a common clinical symptom in the digestive system, with obscure origins and complex mechanisms. Its etiology can be attributed to organic diseases and various Functional Gastrointestinal Disorders (FGIDs). In recent years, the roles of Small Intestinal Bacterial Overgrowth (SIBO), Oral-Cecal Transit Time (OCTT), and gut microbiota dysbiosis in Functional Abdominal Bloating/Distention (FAB/D) have garnered increasing attention. Currently, there is a lack of diagnostic tests and effective treatment measures for patients with bloating. The hydrogen/methane breath test is a safe, economical, and non-invasive examination recommended for diagnosing SIBO. Rifaximin, an antibiotic that acts exclusively in the intestines, has been widely validated for its efficacy in SIBO and in patients with SIBO co-occurring with Irritable Bowel Syndrome (IBS). However, research on the role of SIBO in the production of bloating symptoms and the extent to which rifaximin treatment of SIBO alleviates symptoms in clinical bloating patients is still lacking. This study aims to investigate the efficacy of rifaximin in patients with SIBO who primarily present with bloating. Exploring clinical treatment options for bloating provides a reference for its management. Furthermore, questionnaires on psychiatric symptoms and fecal microbiota analysis for patients with bloating-type SIBO can help clarify the etiology of bloating, offering a basis for the etiological treatment of bloating patients in the next steps.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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• Age between 18 and 70 years, both genders included.

• No special gastrointestinal discomfort such as bloating or abdominal pain, regular bowel movements, and normal stool characteristics.

• Negative hydrogen/methane breath test.

• Age between 18 and 70 years, both genders included.

• Chief complaints of abdominal bloating and/or distension; outpatients with abdominal bloating and/or distension more prominent than other symptoms.

• Positive hydrogen/methane breath test.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Xiuli Zuo, MD,PhD
zuoxiuli@sdu.edu.cn
15588818685
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 115
Treatments
No_intervention: Healthy group
The healthy group met the inclusion and exclusion criteria, and stool samples were retained for microflora analysis as control.
Experimental: Patient group
Patients were required to collect stool samples and score a psychopsychological questionnaire. After enrollment, patients were given Rifaximin dry suspension 0.4g bid for 2 weeks. During the medication period, patients' drug consumption and adverse reactions were recorded through diary cards. After 2 weeks of medication, diary cards and outer packaging of drugs were collected, and case report forms were supplemented. Stool samples were collected again, anxiety and depression scale scores were performed, and clinical symptom changes were recorded. The breath test was reviewed 1 month after the end of the medication, and follow-up was conducted 3 months and 6 months after the end of the medication.
Sponsors
Leads: Xiuli Zuo

This content was sourced from clinicaltrials.gov